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SAFER SPINE SURGERY?

Thu, 22 May 2008 12:33:26 -0400

Can we make spine surgery even safer? Preliminary data from a postmarketing study of SpineVision®’s PediGuard™ device suggest there is a very strong clinical trend that using PediGuard makes spine surgery safer—not only for patients but for surgeons too.

PediGuard is the first and only FDA-cleared Class II device for real-time detection of possible penetration outside the vertebral pedicle. Accuracy of pedicle screw placement is still an issue in spine surgery: published rates of intraoperatively “misplaced” pedicle screws range from 10 to 40 percent, some of which result in pathological consequences such as spinal cord damage, including paraplegia or tetraplegia. Consequently, liability risks for spine surgeons are high.

In this episode, Dr Randy Betz, an orthopaedic spine surgeon and Chief of Staff at Shriners Hospitals for Children, Philadelphia, who is Principal Investigator for an ongoing, multi-site, randomized postmarketing study of PediGuard, presents the study’s preliminary data.

DNA VACCINES

Wed, 14 May 2008 12:46:03 -0400

Researchers at the Centers for Disease Control and Prevention reported in the November 2007 issue of JAMA that conventional vaccines have cut disease deaths by 99%, but have been limited to only 13 disease targets. DNA vaccines, on the other hand, have been touted as some day preventing or curing cancer, AIDS and a litany of other infectious diseases. But the promise of DNA vaccines has been thwarted by a lack of an effective delivery vehicle. In fact, delivering DNA vaccine inside targeted cells has proven to be a formidable challenge. Now, there is growing evidence that suggests vaccine delivery via electroporation might be the answer. In this episode, we speak with Dr. Christian Ottensmeier, Professor of Experimental Cancer Medicine and Senior Clinical Research Fellow at the University of Southampton, one of the UK’s foremost research universities. Dr. Ottensmeier is Principal Investigator for an ongoing Phase I/II clinical study that has two arms: without, and with, the use of Inovio Biomedical’s electroporation system to deliver DNA vaccine to subjects with prostate cancer. This is an academic study using a vaccine developed at the University of Southampton with the support of the Leukemia Research Fund and Cancer Research UK.Dr. Ottensmeier reported early human data from his study at this year’s AACR (American Association for Cancer Research) annual meeting—data which suggest that use of electroporation to enhance the potency and delivery of DNA Vaccines has significant potential.

HOSPITAL-ACQUIRED INFECTIONS

Wed, 14 May 2008 12:14:35 -0400

In the United States, attempts to control hospital-acquired (“nosocomial”) infections are proving ineffective, according to the Government Accountability Office (GAO). In fact, hospital-acquired infections are estimated to be one of the top-ten causes of death in the U.S., claiming 90,000 lives every year. In this episode, we look at how Dijon Hospital in Dijon, France, is protecting its most vulnerable patients with a new mobile infection control technology from AirInSpace. The company’s device, called PlasmairT2006, was recently cleared by the FDA to be used in U.S. hospitals. At Dijon Hospital, there are 40 mobile Plasmair™ units being used in the pediatric and adult haematology wards, where immunocompromised cancer patients are at high risk from deadly airborne pathogens such as aspergillosis. We speak with two doctors at Dijon Hospital: Dr. Denis Caillot, head of Clinical Haematology, and his colleague, Dr. Ludwig Aho, head of Hospital Hygiene and Epidemiology.

VANISHING STENTS - PART 2

Thu, 8 May 2008 14:02:00 -0400

What if there were a stent that could promote natural remodeling of an injured artery after angioplasty, and then just disappear? "Just three years ago bioresorbable stents seemed to be more of a nice to have than a need to have. After all, drug-eluting stents (DES) were seen as the answer to restenosis and showed very minimal risks to patient safety. Johnson & Johnson and Boston Scientific had the clear lead in introducing Cypher and Taxus, respectively, to the interventional community, with Medtronic, Guidant, and Abbott Laboratories bringing up the rear. Then in September 2006 at the World Congress of Cardiology meeting...DES were linked to a four-letter word delivering a new danger corporate executives once again began asking a question they thought they had answered: why deploy a permanent implant on a short-term mission of clearing a coronary artery?" (Source: 'Bioabsorbable Stents', Start-Up, January 2007) In part two of “Vanishing Stents”, we again consider Paris-based ARTERIAL REMODELING TECHNOLOGIES ("ART"). ART's stent is designed to provide the requisite initial acute mechanical scaffolding, but, as it dismantles due to bioresorbability, the possibility of arterial remodeling returns to the artery. Our expert is Antoine Lafont, MD, PhD, Professor of Medicine at the University of Paris; Head of Interventional Cardiology at Georges Pompidou Hospital in Paris; and, Chairman of the Interventional Cardiology Group of the European Society of Cardiology (ESC). Dr. Lafont is a co-founder of ART.

NANOMEDICINE AND TARGETED CANCER THERAPY SERIES

Thu, 24 Apr 2008 14:23:21 -0400

One in four deaths in the U.S. is from cancer, making it the second-leading cause of death after heart attack. Radiation therapy—also called radiotherapy, x-ray, or irradiation—is typically used to kill cancer cells and shrink tumors. Radiation therapy injures or destroys cells in the area being treated by damaging their genetic material, making it impossible for these cells to continue to grow and divide. The goal of radiation therapy is to damage as many cancer cells as possible, while limiting harm to nearby healthy tissue. About half of all cancer patients receive some type of radiation therapy, which may be used alone or in combination with other cancer treatments, such as chemotherapy or surgery. Radiation therapy may be used to treat almost every type of solid tumor. Radiation dose to each site depends on a number of factors, including the type of cancer and whether there are tissues and organs nearby that may be damaged by radiation. In these episodes, we’ll speak with leading radiation-oncologists and other experts about how a Paris-based company, Nanobiotix, is using technology that it calls “nanoXray” to resolve radiation therapy’s biggest drawback: destruction of healthy tissue and its subsequent deleterious side effects when a high dose of x-ray is necessary. The Company believes that nanoXray offers the potential for a dramatic innovation in cancer therapy, based on a technology that is designed to allow destruction of cancer cells only—a new treatment weapon that could be used alone, or in concert with existing anticancer protocols: chemotherapy, surgery, and immunotherapy. Because nanoXray does not interact with healthy cells, it is expected to prevent the toxic side effects associated with chemotherapy.

Elsa Borghi, MD, Medical Director, Nanobiotix. Previously, Dr. Borghi worked in the R&D oncology department for Sanofi-Aventis, one of the five largest pharmaceutical companies in the world, until the onset of 2008, when she joined Nanobiotix.

This podcast is one in a series called: Nanonmedicine & Targeted Cancer Therapies, which can be found at www.medtechmatters.com